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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025608
Receipt No. R000028748
Scientific Title A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Date of disclosure of the study information 2017/01/11
Last modified on 2019/07/16

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Basic information
Public title A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Acronym A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title:Acronym A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Region
Japan

Condition
Condition Repsratory Syncytial virus: RSV
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A study of the efficacy of pranlukast hydrate for infant patients with acute wheezing caused by RS virus infection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate whether internal use of pranlukast from an early stage after hospitalization contributes to the reduction of symptom within onset one month in children hospitalized with acute wheezing caused by RS virus infection.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In intervention group, PO 7mg/kg per day as pranlukast hydrate, in 2 divided doses for 28days in addition to supportive care as usual
Interventions/Control_2 In control group, supportive care as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 months-old <
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria Children hospitalized with RSV bronchiolitis
Key exclusion criteria Children with comorbidity
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Sato
Organization Nagoya University Hospital
Division name Centor for Maternal-Neonatal Care
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-741-2111
Email yoshiaki@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Suguru
Middle name
Last name Takeuchi
Organization Nagoya University Graduate School of Medicine
Division name Pediatrics/Developmental pediatrics
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-741-2111
Homepage URL
Email suguru-t@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel 052-741-2111
Email ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
2017 Year 05 Month 18 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 10 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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